Types of Purified Water Systems in Pharmaceuticals

Pharmaceutical industries require high-quality water for manufacturing, cleaning, and formulation. Different water systems are designed to meet specific pharmacopeial standards (USP, EP, IP, JP) depending on their intended use.

1. Purified Water (PW)

• Obtained through distillation, reverse osmosis (RO), deionization (DI), or ultrafiltration.

• Used in formulations, cleaning, and reagent preparation (except for parenterals).

2. Water for Injection (WFI)

• Produced by distillation (Multi-Effect Distillation – MED or Vapor Compression – VC).

• Must meet stringent microbial and endotoxin limits.

• Used for parenteral dosage forms, sterile preparations, and equipment cleaning.

3. Highly Purified Water (HPW) (as per European Pharmacopoeia)

• Similar to WFI in quality but can be produced using reverse osmosis and ultrafiltration, not necessarily distillation.

• Used for non-parenteral sterile preparations.

4. Sterile Purified Water

• Purified water that has been sterilized.

• Used in aseptic preparations where sterility is required.

5. Sterile Water for Injection (SWFI)

• Packaged in single-dose containers.

• Free from antimicrobial agents.

• Used as a diluent for injectable products.

6. Bacteriostatic Water for Injection (BWFI)

• Sterile WFI with antimicrobial preservative.

• Used in multi-dose vials for injections.

7. Sterile Water for Inhalation

• Similar to SWFI but without bacteriostatic agents.

• Used for inhalation therapy solutions.

8. Sterile Water for Irrigation

• Large-volume containers.

• Not for injection use, but for urological, surgical, and wound irrigation.

9. Sterile Water for Hemodialysis

• Meets chemical and microbial requirements.

• Used for diluting hemodialysis concentrates.

✅ These systems are selected based on intended pharmaceutical use, regulatory requirements, and risk of microbial/endotoxin contamination.

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